Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT07041918
Eligibility Criteria:
INCLUSION CRITERIA
Male or female volunteers between the ages of 18 and 60, as defined in the target population during screening,
Body Mass Index (BMI) between 18 and 32 during screening,
No pregnancy or risk of pregnancy for women,
Willing to participate and provide written informed consent and comply with the study restrictions,
Must not have participated in any clinical trial within 2 months prior to the start of the study,
Must be able to communicate with the researcher or authorized personnel.
EXCLUSION CRITERIA
Platelet dysfunction syndrome,
Critical thrombocytopenia,
Hemodynamic instability,
Septicemia,
Local infection at the site of the procedure,
Autoimmune diseases,
History of chronic infections,
Chronic liver pathology,
Patients receiving anticoagulant/antiplatelet therapy,
Use of NSAIDs (except for paracetamol) in the last 7-10 days,
History of alcohol and/or drug addiction,
Corticosteroid use,
Fever or illness in the past week,
Cancer (especially blood and bone cancers),
Hemoglobin (HGB) levels below 10 g/dl or above 16.5 g/dl in men and 16 g/dl in women,
Platelet count below 105/μl,
Those under immunosuppressive therapy,
Any condition or disease detected during the medical interview/physical examination that, in the opinion of the researcher or designated personnel, would make the volunteer unsuitable for the study, put them at unnecessary risk, or interfere with the volunteer's ability to complete the study,
Clinically significant deviation from normal findings in the physical examination, including vital signs,
Patients planning pregnancy or not using contraception,
Patients using hormonal contraceptive methods to prevent pregnancy,
Breastfeeding women,
Poor venous access for blood sampling,
Plasma or blood donation within the last 2 months,
It is recommended to select patients who do not use tobacco products during the study, as it is considered that it may affect the product's performance.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT07041918
Study Brief:
Protocol Section:
NCT07041918